FDA Registration
Active
🇩🇰 Denmark
45 NeedleGuide Assistant
Reg #: 3007020251
·
FEI: 3007020251
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- UNION MEDICO APS
- Registration Number
- 3007020251
- FEI Number
- 3007020251
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Fruebjergvej 3
- City
- Copenhagen Hovedstaden
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K033696
Owner / Operator
- Firm Name
- Union Medico Aps
- Operator Number
- 10087053
- Address
- Fruebjergvej 3
- City
- Copenhagen
- State
- Hovedstaden
- Postal Code
- 2100
- Country
- DK
- Correspondent
- Michael Perthu
US Agent
- Business Name
- Martensen Wright PC
- Contact Name
- Edward Wright
- Address
- One Capitol Mall, Suite 670
- City
- Sacramento
- State
- CA
- ZIP
- 95814
- Country
- US
- [email protected]
- Phone
- 916 4489088
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Syringe Needle | KZH | Class 2 | General Hospital | No | 2023-01-06 |
Proprietary Names
45 NeedleGuide Assistant
90 NeedleGuide Assistant
Establishment Types
Manufacture Medical Device